A phase I, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of single and multiple ascending doses of GDC-6599 and the effect of food on the pharmacokinetics and pharmacodynamics of GDC-6599 in healthy adult subjects
- Conditions
- Asthma10024970
- Registration Number
- NL-OMON52277
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 92
- Signed Informed Consent Form
- Age 18*75 years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator*s judgment
- Body mass index of 18*30 kg/m2 at screening
- Veins suitable for venipuncture and/or cannula insertion to accommodate blood
sample collection at multiple timepoints during the study
- Pregnant or breastfeeding, or intending to become pregnant during the study
or within 14 days after the final dose of study drug during the SAD/FE stage
and for 28 days after the final dose of study drug during the MAD stage, unless
a longer period is required by local regulations or ethics committee
Women must have a negative serum pregnancy test result within 1 day prior to
initiation of study drug.
- History of easy bruising or bleeding (i.e., bruising or bleeding out of
proportion to the degree of trauma)
- Use of anticoagulant or anti-platelet therapies
- History of significant hepatic impairment, defined as Child-Pugh Class B or
C, corresponding to a Child-Turcotte-Pugh Score >= 7
- History of abuse, in the investigator's judgment, of drugs including, but not
limited to the following: amphetamines, barbiturates, benzodiazepines, cocaine,
marijuana/cannabis, methadone, methamphetamine, ecstasy, morphine/opiates,
phencyclidine, and tricyclic antidepressants within 12 months prior to
screening and clinic admission
A positive drug screen test for any of the drugs listed above at screening is
exclusionary.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Incidence and severity of adverse events, with severity determined according<br /><br>to the DAIDS toxicity grading scale<br /><br>- Change from baseline in targeted vital signs<br /><br>- Change from baseline in targeted clinical laboratory test results<br /><br>- Change from baseline in ECG parameters</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Plasma concentration of GDC-6599 at specified timepoints<br /><br>- Plasma concentration of GDC-6599 at specified timepoints in subjects<br /><br>receiving GDC-6599 under fasting and fed conditions</p><br>